ISOSORBIDE MONONITRATE- isosorbide mononitrate tablet, coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ISOSORBIDE MONONITRATE (UNII: LX1OH63030) (ISOSORBIDE - UNII:WXR179L51S)

Available from:

West-ward Pharmaceutical Corp

INN (International Name):

ISOSORBIDE MONONITRATE

Composition:

ISOSORBIDE MONONITRATE 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Isosorbide mononitrate is indicated for the prevention and treatment of angina pectoris due to coronary artery disease. The onset of action of oral isosorbide mononitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode. Allergic reactions to organic nitrates are extremely rare, but they do occur. Isosorbide mononitrate is contraindicated in patients who are allergic to it.

Product summary:

Isosorbide Mononitrate Tablets 20 mg: white coated, round, scored tablet; embossed "WW33".     Bottles of 30 tablets.     Bottles of 90 tablets.     Bottles of 100 tablets.     Bottles of 1000 tablets. Store at 20-25°C (68-77°F). [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured by: West-ward Pharmaceutical Corp. Eatontown, NJ 07724 USA  Revised April 2006

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ISOSORBIDE MONONITRATE- ISOSORBIDE MONONITRATE TABLET, COATED
WEST-WARD PHARMACEUTICAL CORP
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ISOSORBIDE MONONITRATE TABLETS
RX ONLY
DESCRIPTION
Isosorbide mononitrate, an organic nitrate, is a vasodilator with
effects on both arteries and veins. The
molecular formula is C H NO and the molecular weight is 191.14. The
chemical name for isosorbide
mononitrate is 1,4:3,6-Dianhydro-D-glucitol 5-nitrate and the compound
has the following structural
formula:
Isosorbide mononitrate tablets, for oral administration, contain 20 mg
of isosorbide mononitrate. In
addition, each white tablet contains the following inactive
ingredients: Colloidal Silicon Dioxide,
Dibasic Ammonium Phosphate, Lactose Monohydrate, Microcrystalline
Cellulose, Povidone, and
Sodium Starch Glycolate. Film coating contains: Hydroxypropyl
Methylcellulose, Polyethylene Glycol,
and Titanium Dioxide.
CLINICAL PHARMACOLOGY
Isosorbide mononitrate is the major active metabolite of isosorbide
dinitrate (ISDN), and most of the
clinical activity of the dinitrate is attributable to the mononitrate.
The principal pharmacological action of isosorbide mononitrate is
relaxation of vascular smooth
muscle and consequent dilatation of peripheral arteries and veins,
especially the latter. Dilatation of the
veins promotes peripheral pooling of blood and decreases venous return
to the heart, thereby reducing
left ventricular end-diastolic pressure and pulmonary capillary wedge
pressure (preload). Arteriolar
relaxation reduces systemic vascular resistance, systolic arterial
pressure, and mean arterial pressure
(afterload). Dilatation of the coronary arteries also occurs. The
relative importance of preload
reduction, afterload reduction and coronary dilatation remains
undefined.
PHARMACODYNAMICS: Dosing regimens for most chronically used drugs are
designed to provide plasma
concentrations that are continuously greater than a minimally
effective concentration. This strategy is
inappropriate for organic nitrates. Several well-controlled clinical
trials have used exer